Cesarean Scar PregnancyNCT03218059
Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
A study testing Methotrexate Combined With Transvaginal Surgery in people with Cesarean Scar Pregnancy and Menstruation, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cesarean Scar Pregnancy, Menstruation
- What is being tested?
- Methotrexate Combined With Transvaginal Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.
Who cannot join
- All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, Shanghai Municipality, 201204
Xipeng Wang, 0086-13817806602, xipengwang@hotmail.com
About this study
Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D\&C in the treatment of CSP.
- Conditions
- Cesarean Scar Pregnancy, Menstruation
- Being tested
- Methotrexate Combined With Transvaginal Surgery
- Keywords
- Cesarean Scar Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate Combined With Transvaginal SurgeryProcedure or surgery
Also called Uterine Artery Embolization Combined With Uterine Curettage
The methods of treatment of CSP
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of menstruation by questionnaire
Duration of menstruation
Measured: six months after treatment
Endocrine level by blood examination
FSH in IU/L
Measured: six months after treatment
Volume of menstruation by questionnaire
in pictorial blood loss score
Measured: six months after treatment
Secondary outcomes (2)
The length of the CSD by MRI
millimeter
Measured: six months after treatment
The depth of the CSD by MRI
millimeter
Measured: six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start15 Jul 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xipeng Wang, Study chair, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218059
- Sponsor's protocol ID
- ShanghaiFMIH-CSP Treatment
- Status last verified
- Jan 2017
- First submitted
- 12 Mar 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
- ClinicalTrials.gov ID
- NCT03218059
- Acronym / sponsor ID
- ShanghaiFMIH-CSP Treatment
- Conditions
- Cesarean Scar Pregnancy, Menstruation
- Keywords
- Cesarean Scar Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D\&C in the treatment of CSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.
Key exclusion criteria (1 listed)
- All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate Combined With Transvaginal SurgeryAlso: Uterine Artery Embolization Combined With Uterine CurettageThe methods of treatment of CSP | Procedure or surgery | – |
Primary outcome
Duration of menstruation by questionnaire
Time frame: six months after treatment
Duration of menstruation
Endocrine level by blood examination
Time frame: six months after treatment
FSH in IU/L
Volume of menstruation by questionnaire
Time frame: six months after treatment
in pictorial blood loss score
2 secondary outcomes
The length of the CSD by MRI
Time frame: six months after treatment
The depth of the CSD by MRI
Time frame: six months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
Related trials for Cesarean Scar Pregnancy
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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Effect of Methotrexate on Blood Loss During Laparoscopic Management of CS Scar Pregnancy
Cesarean Scar Pregnancy
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Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Recruiting
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
RecruitingObservational study
Relation Between Type of Scar Pregnancy and Number of Previous Cesarean Sections
Scar Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xipeng Wang study chair
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate Combined With Transvaginal Surgery in people with Cesarean Scar Pregnancy and Menstruation, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xipeng Wang (0086-13817806602, xipengwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of menstruation by questionnaire (time frame: six months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.